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Blood ; 138:985, 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1582151


Background and Objectives: The COVID-19 (CO19) pandemic caused by SARS-CoV-2 remains a significant issue for global health, economics, and society. Several reports have shown that African Americans (AA) have been disproportionately affected by the CO19 pandemic. Limited data have suggested that sickle cell disease (SCD) could be one of the several reasons for higher morbidity and mortality related to CO19 among AA. Recent reports have suggested higher-than-average morbidity and mortality related to CO19 among patients with SCD. We conducted a retrospective, single-institution study in adult patients with SCD who were diagnosed with CO19 infection and their outcomes. Methods: After IRB approval, we conducted a chart review of adult patients (greater than 18 years) with SCD who were diagnosed with CO19 infection between March 1st, 2020, and March 31st, 2021. We recorded demographic data including age, gender, social factors (the type of insurance, availability of primary care provider (PCP), living alone/not), clinical parameters (type of SCD, co-morbidities), outpatient management of SCD, and how CO19 infection was managed like inpatient admission and complications. In patients who were admitted or seen in the emergency department (ED), we collected additional data including vitals, labs, the severity of illness, complications, length of stay, and outcomes. Computations were performed using statistical software SAS 9.4 for Windows. Results: We found a total of 51 patients with SCD diagnosed with CO19 infection in the above period. The median age of patients was 30 years. 61% were females and 39 % were males. All of them were AA. 11.76% were living alone, 49.02% were living with family, 1.96% (1 patient) was institutionalized, and the living situation was unknown in 37.25%. Most of the patients had Medicaid Insurance (52.94%), Medicare in 33.3%, private insurance in 13.73 % and 2% were uninsured. Only 64.71% of patients had a PCP. 60% had HbSS disease, 32% had HbSC disease, 4% had HbS-beta thalassemia, one patient each had HbSS with hereditary persistence of HbF and HbS/HbD. Comorbidities and previous history included acute chest syndrome in 65.96%, avascular necrosis in 36.96%, leg ulcers in 8.7%, hypertension in 8.7%, sickle cell retinopathy in 14.57%, cerebrovascular disease in 26.19%, chronic kidney disease in 7.69%, venous thromboembolism (VTE) in 20.41%, 10.41% were on anticoagulation, history of HIV and hepatitis C infection in 6.38%. 28.21% of patients were maintained on partial exchange transfusions as an outpatient for various indications. 72.73% were on hydroxyurea, 7.5% were on crizanlizumab, 5.26% were on voxelotor and 26.83% were on iron chelation. Vitals and pertinent lab values on initial assessment were recorded and many patients had missing data. On presentation, 25.53% were febrile, 29.17% of patients were tachycardic, 31.25% were hypoxic (SpO2 < 95%), 38.46% were tachypneic, 59.18% had a body mass index (BMI) of > 24.9. Median hemoglobin and hematocrit were 8.9/27.4 g/dL. The median white blood cell count was 9490/uL and platelets were 315,000/uL. Median ferritin was 1573 ug/L. Median bilirubin and creatinine were 2.05 mg/dL and 0.86 mg/dL. The patients were further stratified based on the clinical location where CO19 infection was managed (Table 1). 39.3% were diagnosed in the outpatient setting/ED and 60.3% in the inpatient setting. Among 51 patients, 5.71% (n=2) required ICU admission and was mechanically ventilated. 17.5% received dexamethasone, 7.69% received remdesivir, 2.76% received convalescent plasma, 17.07% had infections and 47% received antibiotics. Only one patient received an exchange transfusion during admission. One patient developed a new VTE after CO19 infection. On statistical analysis, the only factor which impacted the clinical location of management was tachycardia (P=0.007). Of the 51 patients, only 3.9% (2 patients) died of complications of CO19 infection, one with hypoxic respiratory failure, disseminated intravascular coagulation, shock, and the other one with pulmonary mbolism. 13% were readmitted within a month, one of them was admitted with a new pulmonary embolism and the others were admitted for acute painful episodes. Conclusion: We found a mortality rate of 3.9% in our single-center study of patients with SCD and CO19 infection. This mortality rate is lower than other published experiences in patients with SCD and CO19 infection. [Formula presented] Disclosures: Master: Blue Bird Bio: Current holder of individual stocks in a privately-held company.

European Heart Journal ; 42(SUPPL 1):3177, 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1554235


Background: The COVID-19 pandemic has curtailed clinical trial activity significantly. Decentralized clinical trial (DCT) designs may lower cost, expand trial access, and reduce exposure risk for patients and staff. Whether such designs can be used for large, pivotal drug trials is not known. Purpose: We performed a feasibility study to inform whether a large phase 3 Cardiovascular DCT can achieve high quality trial results and also withstand health crises such as the COVID-19 pandemic. The DeTAP (Decentralized Trial in Afib Patients) was a single-arm, observational study that integrated a suite of digital health technologies, including paired home sensor devices, into a 100% virtual trial experience for atrial fibrillation (AF) patients on anticoagulation. Methods: We recruited 100 AF patients over age 55 on oral anticoagulation (OAC) by traditional methods or by social media ads placed Californiawide. Subjects completed an online prescreening, uploaded their active OAC prescription, and completed an e-consent via SMS message link. Participants downloaded a customized study app to integrate surveys and data from study-supplied wireless blood pressure (BP) and 6 lead EKG sensors (Figure 1A). Participants completed pre- and post-study engagement surveys, weekly OAC adherence surveys, 4 study televisits, 4 ECG/BP readings, and 4 post-study surveys over a 6 month period. The primary endpoints were protocol engagement-based measurements that quantified percent completion of: 1) televisits 2) surveys, 3) ECG/BP readings requirements. Secondary endpoints were the % changes in: 1) OAC adherence (OACA), 2) nuisance bleeding (NB), 3) individual patient engagement surveys. Results: 100 participants were recruited in 26 days (traditional: 6 in 2 weeks;social media: 94 in 12 days) with a dramatic surge in enrollment driven by social media ads (Figure 1B, Table). A recruitment overflow occurred with >200 eligible candidates on a waitlist. All key study completion metrics showed high compliance: televisit (91%);surveys (85%);ECG/BP completion (90%). Overall OACA was unchanged, but for subjects who reported low initial OACA, there was significant improvement at 6 months (85±16% to 98±6%;p=0.002). 47 participants (57%) reported NB, which did not correlate with OACA. Participant engagement measure scores (PAM-13) trended higher (baseline, 70%;6 months, 74%, p=0.32). Lastly, study participants exhibited strong interest in participating in a larger experimental drug DCT study (90%) in the future. Conclusion: The DeTAP study, conducted fully during the COVID-19 pandemic, demonstrates that a decentralized CV medical intervention trial is feasible and can achieve rapid recruitment, high study retention, physiologic and adverse event reporting, and high study engagement via the proper integration of digital technologies and a dedicated DCT study coordination effort. These findings could be informative for virtualizing large pivotal clinical trials at scale.